The present invention relates to a vaginal device for therapeutic and diagnostic purposes, and more particularly to a resilient vaginal insert that exerts pressure upon the vaginal walls to diagnose and treat various types of pelvic floor defects including urinary incontinence and also to a system for the controlled and sustained delivery of pharmacological compounds for treatment of various diseases inside or outside the genital tract.
A significant number of women suffer from urinary stress incontinence, primarily as a consequence of stresses to the musculature of the pelvic floor and ligaments supporting the bladder experienced during childbirth. Surgical remedies and apparatus to aid this condition are known, such as that disclosed in U.S. Pat. No. 5,899,909 relating to a method and apparatus for placing a supportive surgical tape beneath the urethra. Surgery is contraindicated in some patients, however, due to intolerance to anesthesia, preference or other reasons. In addition to surgical treatments for incontinence, it has been known for many years that a suitably proportioned object placed within the vagina proximate to the urethra and/or bladder can be used to support, reposition and/or constrict the urethra and/or bladder to ameliorate incontinence. For example, an inflatable toroidal bladder (U.S. Pat. No. 5,007,894) and a five-sided plate with a U-shaped indentation for supporting/occluding the urethra (U.S. Pat. No. 4,139,006) have been proposed for vaginal insertion to treat incontinence. Certain of the proposed vaginal inserts are formed from resilient material, member with a bladder neck cradle (U.S. Pat. No. 5,036,867) and a folding insert having legs that resiliently urge against the vaginal wall to exert pressure on the urethra (U.S. Pat. No. 5,618,256).
The foregoing apparatus having varying degrees of effectiveness, ease of use, ease of removal, associated discomfort and hygienic impact. Accordingly, it remains an objective in the art to provide a vaginal insert addressing a variety of disorders, such as, urinary incontinence, that is maximally effective, comfortable, easy to use and hygienic.
Further, there are numerous conditions outside and within the genital and/or urogenital tract, such as hormonal dysfunctions, cancer, inflammation, infection or incontinence that may be treated by pharmaceutically active compounds. Many of these compounds are presently orally administered, In certain instances, however, this is a disadvantage, viz., when systemic delivery is used to treat a condition or disease that is more effectively treated by local application. Accordingly, it would be desirable to provide a sustained or controlled drug delivery device that is capable of delivery of the drug for an extended period of time, preferably one week or longer. It would be even more desirable to combine a drug delivery device with an apparatus for treating other clinical ailments.
The limitations of known vaginal inserts for treating disease are addressed by the present invention, which includes a vaginal insert having a body formed from a flexible material permitting the body to be coiled into a coiled state to form a generally cylindrical configuration. The body exhibits a resilient bias toward uncoiling and expanding in diameter from the coiled state. The insert is insertable into a vagina in the coiled state and is expandable therein to press against the vaginal wall as the body exhibits its resilient bias.
A method in accordance with the present invention for treating disease with a vaginal insert includes coiling the insert into a coiled state; inserting the insert into a vagina; and allowing the insert to expand, thereby contacting and pressing against the interior walls of the vagina.